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Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis

2026年5月23日 更新者：Qiancheng Xu、First Affiliated Hospital of Wannan Medical College

Changes in Regional Ventilation-Perfusion Match Following Percutaneous Transluminal Angioplasty for Arteriovenous Graft Thrombosis: A Prospective Observation Pilot Study

Patients with end-stage renal disease (ESRD) often require arteriovenous grafts (AVG) for hemodialysis. AVG thrombosis is a common complication, usually managed by percutaneous transluminal angioplasty (PTA) to restore blood flow. PTA achieves patency by balloon-mediated compression and fragmentation of thrombus. Small thrombus fragments may enter the venous circulation and cause transient pulmonary microembolism, leading to ventilation-perfusion (V/Q) mismatch. This study uses electrical impedance tomography (EIT) to noninvasively monitor short-term changes in regional ventilation and perfusion during and after PTA, exploring the immediate pulmonary physiological consequences of thrombus fragmentation and revascularization in dialysis patients.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Arteriovenous graft (AVG) thrombosis is a major source of vascular access failure in ESRD. PTA restores patency through balloon dilation and mechanical thrombus compression. Minor embolic debris can reach the pulmonary bed, transiently disturbing perfusion distribution and V/Q matching. Because the pulmonary circulation is sensitive to sudden peripheral hemodynamic shifts, the PTA period provides a unique opportunity to observe lung perfusion response dynamically.

This single-center, prospective, observational pilot study will continuously record regional ventilation and perfusion by EIT at six time points: 10 min before PTA, at recanalization, and 10, 20, 30 min after, and at procedure completion. Measured variables include: V/Q matching index (primary), physiological dead space fraction (Vd/Vt), intrapulmonary shunt fraction, SPO₂/FiO₂ ratio, and hemodynamic data (balloon pressure, recanalization time, blood flow recovery). Results will be analyzed using repeated-measures ANOVA or mixed-effects modeling.

研究类型

观察性的

注册 (估计的)

20

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
      • Wuhu、中国
        • 招聘中
        • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with end-stage renal disease (ESRD) undergoing maintenance hemodialysis who present with thrombosed arteriovenous grafts (AVG) requiring clinically indicated percutaneous transluminal angioplasty (PTA) to restore patency. The study population will consist of adult patients (18-80 years) admitted to the interventional radiology or dialysis access unit of the First Affiliated Hospital of Wannan Medical College (Yijishan Hospital). All participants will receive routine PTA treatment as part of standard care. EIT monitoring will be applied non-invasively to collect ventilation and perfusion signals before and after PTA. No additional interventions beyond routine clinical management will be introduced.

描述

Inclusion Criteria

  1. Age ≥ 18 years.
  2. Diagnosis of end-stage renal disease receiving maintenance hemodialysis.
  3. Documented AVG thrombosis requiring PTA.
  4. Able to cooperate and tolerate EIT monitoring.
  5. Provided written informed consent.

Exclusion Criteria

  1. Severe respiratory failure incompatible with supine position.
  2. Thoracic skin condition or deformity preventing EIT electrode placement.
  3. Acute pulmonary embolism or acute pulmonary edema before procedure.
  4. NYHA Class IV heart failure or hemodynamic instability.
  5. Pregnancy or breastfeeding.
  6. Any other circumstance judged unsuitable by investigator.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Observation Cohort
All enrolled patients will undergo clinically indicated PTA under standard care. EIT monitoring will be performed continuously before, during, and after recanalization to record regional ventilation and perfusion data. No experimental drug or device will be administered beyond routine care.
诊断测试：Electrical Impedance Tomography (EIT) Monitoring
Non-invasive 16-electrode EIT belt applied at the 4th intercostal level. Continuous data acquisition begins 10 min pre-PTA, continues throughout balloon angioplasty, and up to 30 min post-recanalization. No alteration to standard clinical care.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Ventilation-Perfusion Matching Index
大体时间：Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Quantitative index derived from EIT ventilation and perfusion maps, indicating spatial regional correlation of air and blood flow distribution.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

次要结果测量

结果测量
措施说明
大体时间
Change in Peripheral Oxygen Saturation
大体时间：Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Change in Physiological Dead Space Fraction
大体时间：Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Ratio of physiologic dead space to tidal volume, calculated by EIT validated algorithm, reflecting inefficiency of ventilation.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Change in Intrapulmonary Shunt Fraction
大体时间：Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Percentage of the lung region showing perfusion without ventilation, estimated from EIT perfusion signals.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Change in Regional Ventilation and Perfusion Distribution
大体时间：Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.
Variation in spatial patterns of pulmonary ventilation and perfusion derived from pixel-based EIT data.
Baseline (10 min before PTA), immediate post-recanalization, 10, 20, 30 minutes, and procedure end.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

First Affiliated Hospital of Wannan Medical College

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年10月24日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年5月23日

首先提交符合 QC 标准的

2026年5月23日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年5月29日

上次提交的符合 QC 标准的更新

2026年5月23日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2026-ICU04

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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